Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 128
- Locations
- 3
- Primary Endpoint
- Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria
Study Overview
Brief Summary
In the proposed project the investigators will asses whether changes in expression of selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.
Detailed Description
Blood will be taken
- before anthracycline based chemotherapy administration
- at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)
- after anthracycline chemotherapy cessation
- 6 months after chemotherapy cessation if an end point occurs
- 12 months after chemotherapy cessation if an end point occurs
Echocardiography will be performed
- before anthracycline based chemotherapy administration
- after anthracycline based chemotherapy cessation
- 6 months after anthracycline based chemotherapy cessation
- 12 months after anthracycline based chemotherapy cessation if no end point was observed earlier The investigators will perform high-throughput miRNA(microRNA) expression profiling of serum samples - called training set.
Training set will consist of sera of 30 patients who has reached an end point. Training set will be sequenced using next generation sequencing.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 18-70
- •stage I-III TNM (Tumor Node Metastases)
Exclusion Criteria
- •second or next cancer (except for basal cell skin cancer and CIN)
- •previously treated with chemotherapy
- •previously treated with radiotherapy
- •acute myocardial infarction
- •heart failure
- •cardiomyopathy
Outcomes
Primary Outcomes
Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria
Time Frame: up to 76 weeks after chemotherapy conclusion
either a cardiomyopathy with decreased left ventricular ejection fraction (LVEF), a reduction of LVEF ≥5% to \<55% with symptoms of heart failure (e.g. orthopnoea and paroxysmal nocturnal dyspnoea, elevated jugular venous pressure, S3 gallop, Hepatojugular reflux, tachycardia), or an asymptomatic reduction of LVEF ≥10% to \<55%
Secondary Outcomes
No secondary outcomes reported
Investigators
Bartosz Dąbek
MD
West Pomeranian Cancer Center